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. 2024 Jan 4;14(1):e074949.
doi: 10.1136/bmjopen-2023-074949.

Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial

Iván Caballero  1 , Lirios Dueñas  2 , Mercè Balasch-Bernat  3 , Rubén Fernández-Matías  4 , Luis Bresó-Parra  5 , Cristina Gallego-Terres  6 , Jose Enrique Aroca Navarro  7 , Marta Navarro-Bosch  7 , Jeremy Lewis  8   9 , Enrique Lluch Girbés  3   10
Affiliations

Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial

Iván Caballero et al. BMJ Open. .

Abstract

Introduction: Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.

Methods and analysis: A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.

Ethics and dissemination: Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.

Trial registration number: NCT05478902.

Keywords: Calcification; Exercise Therapy; Extracorporeal Shockwave Therapy; Pain Management; Physical Therapy Modalities; Rehabilitation Medicine; Shoulder Pain.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of study process. ESWT, extracorporeal shockwave therapy; ROM, range of motion; SPADI, Shoulder Pain and Disability Index; SUMS, Shape-Up-My-Shoulder Protocol; US-PICT, ultrasound-guided percutaneous irrigation of calcific tendinopathy; VAS, Visual Analogue Scale.
Figure 2
Figure 2
Pushing programme progression. Used with permission from Lewis and Fernández-de-las-Penas.
See this image and copyright information in PMC

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References

    1. Sansone V, Maiorano E, Galluzzo A, et al. . Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev 2018;10:63–72. 10.2147/ORR.S138225 - DOI - PMC - PubMed
    1. Sansone V, Consonni O, Maiorano E, et al. . Calcific tendinopathy of the rotator cuff: the correlation between pain and imaging features in symptomatic and asymptomatic female shoulders. Skeletal Radiol 2016;45:49–55. 10.1007/s00256-015-2240-3 - DOI - PubMed
    1. Louwerens JKG, Sierevelt IN, van Hove RP, et al. . Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg 2015;24:1588–93. 10.1016/j.jse.2015.02.024 - DOI - PubMed
    1. Leong HT, Fu SC, He X, et al. . Risk factors for rotator cuff tendinopathy: a systematic review and meta-analysis. J Rehabil Med 2019;51:627–37. 10.2340/16501977-2598 - DOI - PubMed
    1. Sansone VC, Meroni R, Boria P, et al. . Are occupational repetitive movements of the upper arm associated with rotator cuff calcific tendinopathies? Rheumatol Int 2015;35:273–80. 10.1007/s00296-014-3086-z - DOI - PubMed

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